Can a tailored chemo cocktail outsmart a common leukemia?

NCT ID NCT06529250

Disease control Sponsor: Institute of Hematology & Blood Diseases Hospital, China Source: ClinicalTrials.gov ↗

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial is testing whether a chemotherapy combination called HAD, given at intermediate doses, works better than the standard regimen for people with a specific genetic subtype of acute myeloid leukemia (AML) known as CEBPA double-mutated. The study enrolls adults aged 14 to 55 with this leukemia type. Participants receive either the HAD regimen or conventional treatment, and researchers compare how long they live without the disease returning or worsening.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: A combination chemotherapy regimen called HAD, which includes homoharringtonine, cytarabine, and daunorubicin, given at intermediate doses.
What this could lead to: If successful, this could establish a more effective first-line chemotherapy for CEBPA double-mutated AML, potentially improving survival and reducing relapse.
What could go wrong: This is a mid-stage trial, and the benefits seen in earlier retrospective studies may not hold up. Chemotherapy carries significant side effects, and the regimen may not be better than standard care.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 148 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 54 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. AML diagnosed according to WHO-2022 classification with recurrent CEBPA mutations and containing mutation in the bZIP domain. 2. Older than 14 years old and younger than 55 years old 3. Male or female. 4. The Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of AML patients were 0-2 points. 5. Meet the following laboratory tests (performed within 7 days prior to treatment) 1) Total bilirubin ≤ 1.5 times of the upper limit of normal value (same age); 2) AST and ALT≤ 2.5 times of the upper limit of normal value (same age); 3) Blood creatinine \< 2 times of the upper limit of normal value (same age); 4) Myocardial enzymes \< 2 times of the upper limit of normal value (same age); 5) Echocardiography (ECHO) was performed to determine the ejection fraction of the heart within the normal range. Exclusion Criteria: 1. Patients who have previously received induction chemotherapy, regardless of efficacy. 2. Simultaneously suffering from malignant tumors of other organs and requiring treatment). 3. Pregnant or lactating women. Male or female patients participating in the trial must take contraceptive measures during the trial treatment period. 4. Active heart disease, defined as one or more of the following:1) Have a history of uncontrolled or symptomatic angina pectoris;2) Myocardial infarction less than 6 months prior to enrollment in the study;3) A history of arrhythmia requiring medication treatment or severe clinical symptoms;4) Uncontrolled or symptomatic congestive heart failure (\> NYHA grade 2);5) The ejection fraction is below the lower limit of the normal range. 5. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis). 6. Those who were not considered suitable for inclusion by the researchers.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia, biallelic CEBPA gene mutation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AML

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can a tailored chemo cocktail outsmart a common leukemia?

What the study statuses mean